GlioblastomaGCCC 19140NCT04181684
LITT Followed by Hypofractionated RT for Recurrent Gliomas
A study testing Procedure: LITT and Hypo-Fractionated Radiation Therapy in people with Glioblastoma and Brain Tumor, run by University of Maryland, Baltimore at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with recurrent gliomas. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Glioblastoma, Brain Tumor, Glioma
- What is being tested?
- Procedure: LITT and Hypo-Fractionated Radiation Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Jan 2020to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with history of a WHO Grade II-IV glioma with radiographic evidence of recurrent or progressive tumor
- Patient must have received prior radiation therapy for initial treatment of glioma
- Patients with any number of recurrences are allowed as long as the patient has not undergone re-irradiation
- Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration
- History and physical including neurological exam within 30 days prior to registration
- Karnofsky performance status ≥ 60% within 30 days prior to registration
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- Age ≥ 22 years old
- Minimum interval since completion of prior radiation treatment is 8 weeks
- Patients will only receive re-irradiation if pathology from LITT is consistent with recurrent tumor
- Patients must have signed an approved informed consent
- Patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for 6 months after study completion.
- Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.
Who cannot join
- Patients that are not surgical candidates for stereotactic biopsy or laser ablation
- Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- History or presence of serious uncontrolled ventricular or significant arrhythmias.
- Any of the following within 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack , pulmonary embolism
- Infratentorial tumor or evidence of leptomeningeal spread
- Inability to undergo a MRI
- Pregnant or breast-feeding women
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
UCH Kaufman Cancer Center
Bel Air, Maryland, 21014
Central Maryland Radiation Oncology
Columbia, Maryland, 21044
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
About this study
Official title: Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas.
The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with recurrent gliomas.
Read the detailed description
Radiation therapy is preferably used as an adjunct to surgery for patients with a newly diagnosed or recurrent glioblastoma. LITT offers an alternative to surgical resection, and due to its minimally invasive nature, does not delay initiating radiation therapy. Another advantage of LITT prior to radiation therapy is the ability to obtain a tissue diagnosis of recurrent tumor prior to initiating radiation therapy.
- Conditions
- Glioblastoma, Brain Tumor, Glioma, Neoplasms
- Being tested
- Procedure: LITT, Hypo-Fractionated Radiation Therapy
- Keywords
- Gliomas, Laser Interstitial Thermal Therapy, Brain, Brain Tumor, Radiotherapy, Proton Therapy, Hypofractionated Radiation Therapy, Malignant, Glioblastoma
- Medical subject headings
- Glioblastoma, Brain Neoplasms, Glioma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: LITTDevice
Also called Laser Interstitial thermal therapy
This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.
Hypo-Fractionated Radiation TherapyRadiation
Treatments will be delivered once daily on consecutive treatment days (typically 5 fractions per week). Radiation therapy simulation is to be performed within 10 days of the LITT procedure.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: LITT with Hypofractionated radiation therapy | Experimental | Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions. Receives: Device: Procedure: LITT; Radiation: Hypo-Fractionated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
To complete protocol treatment without undue treatment-related acute toxicity in recurrent or progressive glioma subjects undergoing LITT followed by hypofractionated radiation therapy.
Measured: 2 years
Secondary outcomes (6)
Progression-free survival at 6 months
To describe progression-free survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy
Measured: 2 Years
Median progression-free survival
To describe median progression-free survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
Measured: 2 Years
Median overall survival
To describe median progression-free survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
Measured: 2 years
1-year overall survival
To describe 1 year overall survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
Measured: 2 years
Overall response rate
To describe overall response survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
Measured: 2 years
Quality of Life before, during, and after treatment
Patient reported quality of life impact from undergoing LITT followed by hypofractionated radiation therapy using the M.D. Anderson Symptom Inventory- Brain Tumor (MDASI-BT) questionnaire.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start8 Jan 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Keep Punching Foundation
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181684
- Sponsor's protocol ID
- HP-00088569
- Acronym
- GCCC 19140
- Status last verified
- Aug 2026
- First submitted
- 24 Nov 2019
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas.
- ClinicalTrials.gov ID
- NCT04181684
- Acronym / sponsor ID
- GCCC 19140 / HP-00088569
- Conditions
- Glioblastoma, Brain Tumor, Glioma, Neoplasms
- Keywords
- Gliomas, Laser Interstitial Thermal Therapy, Brain, Brain Tumor, Radiotherapy, Proton Therapy, Hypofractionated Radiation Therapy, Malignant, Glioblastoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Keep Punching Foundation
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with recurrent gliomas.
Detailed description
Radiation therapy is preferably used as an adjunct to surgery for patients with a newly diagnosed or recurrent glioblastoma. LITT offers an alternative to surgical resection, and due to its minimally invasive nature, does not delay initiating radiation therapy. Another advantage of LITT prior to radiation therapy is the ability to obtain a tissue diagnosis of recurrent tumor prior to initiating radiation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: LITT with Hypofractionated radiation therapy | Experimental | Device: Procedure: LITT, Radiation: Hypo-Fractionated Radiation TherapyLaser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with history of a WHO Grade II-IV glioma with radiographic evidence of recurrent or progressive tumor
- Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration
- History and physical including neurological exam within 30 days prior to registration
- Karnofsky performance status ≥ 60% within 30 days prior to registration
- Age ≥ 22 years old
Key exclusion criteria (7 listed)
- Patients that are not surgical candidates for stereotactic biopsy or laser ablation
- Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- Infratentorial tumor or evidence of leptomeningeal spread
- Inability to undergo a MRI
- Pregnant or breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procedure: LITTAlso: Laser Interstitial thermal therapyThis procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation. | Device | Experimental: LITT with Hypofractionated radiation therapy |
| Hypo-Fractionated Radiation TherapyTreatments will be delivered once daily on consecutive treatment days (typically 5 fractions per week). Radiation therapy simulation is to be performed within 10 days of the LITT procedure. | Radiation | Experimental: LITT with Hypofractionated radiation therapy |
Primary outcome
Adverse Events
Time frame: 2 years
To complete protocol treatment without undue treatment-related acute toxicity in recurrent or progressive glioma subjects undergoing LITT followed by hypofractionated radiation therapy.
6 secondary outcomes
Progression-free survival at 6 months
Time frame: 2 Years
Median progression-free survival
Time frame: 2 Years
Median overall survival
Time frame: 2 years
1-year overall survival
Time frame: 2 years
Overall response rate
Time frame: 2 years
Quality of Life before, during, and after treatment
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: LITT and Hypo-Fractionated Radiation Therapy in people with Glioblastoma and Brain Tumor, run by University of Maryland, Baltimore at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.